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FDA’s 2005 New Molecular Entity Total: 18, Including Five In December

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA clearance of Bayer/Onyx’ Nexavar oncologic Dec. 20, ahead of its Jan. 11, 2006 user fee goal date, helped the agency achieve a total of 18 new molecular entity approvals in 2005.

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New molecular entities that aren’t new to the market

FDA approved two NDAs in the last month as NMEs despite their availability on the U.S. market in other versions that did not go through the Office of New Drugs review process. Novartis' Afinitor (everolimus) cleared the agency March 30 for advanced renal cell carcinoma as an NME, even though everolimus is also the drug component of Abbott's drug-eluting Xcience stent, launched in the U.S. in July 2008 after clearing the device center's approval process. (An earlier organ transplant rejection NDA failed to gain FDA approval, but is available overseas as Certican). Sciele's prescription benzyl alcohol lotion for head lice, approved April 9, was deemed an NME (also referred to as NDA chemical type 1) even though the application used the 505(b)(2), or "paper NDA," pathway that allows data from other uses of the drug to be used in the NDA. While never before the active ingredient in an Rx preparation, benzyl alcohol is widely available under an OTC monograph and as an excipient in approved drug products including solutions for I.V. administration. Benzyl alcohol is hardly the first 505(b)(2) NDA to receive NME status: four hyaluronidase products were approved as 505(b)(2) NMEs in the last half-decade because FDA considered them complex biologic agents that could not be fully characterized (1Pharmaceutical Approvals Monthly January 2006, p. 3)

Nexavar priority review for liver cancer

FDA grants priority review for Bayer/Onyx's Nexavar (sorafenib) sNDA for use in hepatocellular carcinoma, the firms announce Aug. 20. Completed in June, the submission is supported by data from the Phase III SHARP trial, which demonstrated that Nexavar extended overall survival by 44 percent in patients with liver cancer versus placebo. If approved, the multikinase inhibitor would be the first FDA-approved therapy for the treatment of liver cancer. The priority review designation sets the user fee date in February 2008. Nexavar was approved in December 2005 for the treatment of advanced kidney cancer (1Pharmaceutical Approvals Monthly January 2006, p. 3)...

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